The UserWise Blog

The Usability Engineering Process is used to help develop and design safe and effective medical devices that are also usable, ultimately reducing the overall risk of the medical device and improving the customer experience and satisfaction. When implemented early in the design process, it can help a medical device company save money and time by identifying potential use errors in the prototyping phase so design controls and mitigations can be implemented effectively. This blog post outlines the critical phases of the Usability Engineering Process and what they entail for a medical device.

[User Research]

USability Engineering Process for a Medical Device or Combination PRoduct.

What is Early Stage Human Factors Research?

Collect on-market safety data as an input to the medical device design

Find out what people are really thinking through observation at point of medical device use

Actions speak louder than words

Identify environmental, social, and motivational considerations for the design of the medical device

Use appropriate sample, representative of ALL user types

Ask the right questions

[Risk Analysis]

What is Use-Related Risk Analysis?

Methodically identify and record all use errors associated with the medical device

Use this information to improve the medical device design and maximize safety